According to a story from biospace.com, a treatment developed by the pharmaceutical company Pfizer was given Breakthrough Therapy designation by the Food and Drug Administration (FDA). The drug is a Janus kinase 1 inhibitor intended for the treatment of patients with severe atopic dermatitis. The Phase 3 program for the drug began in December.
Severe atopic dermatitis is a condition in which the patient’s skin becomes heavily inflamed. Skin often becomes red, itchy and cracked. An unpleasant clear fluid may ooze from affected areas. The back of the knees and inner fold of the elbows are the areas most commonly affected in children, but people with severe disease may experience symptoms all over the skin. Complications include asthma and hay fever. The hands and feet are commonly affected in adults. There is a heightened risk for skin infections. The exact cause of severe atopic dermatisis is not clear, though there is some evidence for genetic and environmental factors. Allergens and exposure to ‘hard water’ (determined by the concentration of calcium carbonate) could make the risk greater, especially in kids. Click here to learn more about severe atopic dermatitis.
The Breakthrough Therapy Designation was first implemented by the FDA in 2012. A drug that qualified for this designation must be able to treat a life threatening or otherwise serious disease, and data from clinical trials must indicate that the drug indicates a major improvement in effectiveness compared to currently available treatments. This is especially notable if recognized early in the drug’s clinical development. Breakthrough Therapy Designation also allows for a faster paced development and review process for the treatment, which allows the most innovative and effective treatments to reach the patients that desperately need them sooner.